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Dietary Supplement
GlaucoCetin for Glaucoma
N/A
Waitlist Available
Led By Natasha N Kolomeyer, MD
Research Sponsored by Wills Eye
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 20 minute questionnaires during a 6 month period
Awards & highlights
Summary
This trial is testing a daily supplement called GlaucoCetin, which aims to help people with open angle glaucoma. The supplement is designed to protect and support the nerve cells in the eye that are crucial for vision. Researchers want to see if taking GlaucoCetin over several months can improve vision and overall quality of life for these patients.
Who is the study for?
This trial is for people aged 40-80 with open-angle glaucoma, controlled eye pressure, and good visual acuity. Participants must have specific types of visual field defects but no other significant eye diseases or recent surgeries. They shouldn't be on certain medications like nitroglycerin or anti-seizure drugs, nor should they have uncontrolled blood pressure or diabetes.
What is being tested?
The study tests GlaucoCetin, a medical food designed to protect optic nerve cells in glaucoma patients against a placebo over six months. Patients are randomly chosen to receive either the treatment or placebo to see if there's an improvement in vision.
What are the potential side effects?
Potential side effects aren't detailed here but could relate to ingredients in GlaucoCetin such as Curcumin and Ginkgo Biloba which may cause digestive upset or allergic reactions in some individuals.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 20 minute questionnaires during a 6 month period
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~20 minute questionnaires during a 6 month period
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Visual Field Mean Deviation
Secondary study objectives
Perceived Quality of Life Improvement
Perceived Quality of Life Improvement measured by National Eye Institute Visual Function Questionnaire 25 (NEI VFQ-25)
Trial Design
4Treatment groups
Active Control
Placebo Group
Group I: GlaucoCetin Peripheral GroupActive Control1 Intervention
Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with peripheral visual field loss will be randomly assigned GlaucoCetin, a medical food in capsule form.
Group II: GlaucoCetin Central GroupActive Control1 Intervention
Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with central visual field loss will be randomly assigned GlaucoCetin, a medical food in capsule form.
Group III: Placebo Peripheral GroupPlacebo Group1 Intervention
Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with peripheral visual field loss will be randomly assigned a placebo, with no nutritional value, in capsule form.
Group IV: Placebo Central GroupPlacebo Group1 Intervention
Primary Open Angle Glaucoma participants who meet inclusion exclusion criteria with central visual field loss will be randomly assigned a placebo, with no nutritional value, in capsule form.
Research Highlights
Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for glaucoma primarily aim to reduce intraocular pressure (IOP) to prevent damage to the optic nerve. Medications such as prostaglandin analogs increase the outflow of aqueous humor, while beta-blockers and carbonic anhydrase inhibitors reduce its production.
Neuroprotective strategies, like those being studied in GlaucoCetin, focus on supporting and protecting optic nerve cells from degeneration. This is crucial for glaucoma patients as preserving the health of optic nerve cells can slow disease progression and help maintain vision.
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Who is running the clinical trial?
Guardian Health Sciences, Inc.UNKNOWN
Wills EyeLead Sponsor
80 Previous Clinical Trials
15,336 Total Patients Enrolled
49 Trials studying Glaucoma
9,896 Patients Enrolled for Glaucoma
Natasha N Kolomeyer, MDPrincipal InvestigatorWills Eye Hospital
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You are currently using nitroglycerin medication.You have an eye condition that could make it difficult to accurately measure your eye pressure.You have a history of epilepsy or you currently take medicine for seizures.Your eyesight is good, with a vision of 20/40 or better in both eyes.You have had glaucoma surgery within the past 6 months.The liquid surrounding a sample is transparent.You are currently taking medications like clopidogrel or warfarin that prevent blood from clotting.You are not willing to take either the supplement or a fake pill (placebo) for a period of 6 months.You have had an eye injury in the past.You have used biotin, Ginkgo Biloba, or Citicoline in the past 3 months, or any other products containing Glaucocetin in the past 1 month.You have a known disorder that causes bleeding problems.Your high blood pressure or diabetes is not well controlled.You had surgery to remove a cataract from your eye in the last 3 months.You have had a laser eye procedure called selective laser trabeculoplasty in the past 3 months.
Research Study Groups:
This trial has the following groups:- Group 1: GlaucoCetin Peripheral Group
- Group 2: Placebo Peripheral Group
- Group 3: GlaucoCetin Central Group
- Group 4: Placebo Central Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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